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    Chemistry

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    Also known as: Neomycin sulfate, 1405-10-3, Neomycin trisulfate hydrate, Akos016010116
    Molecular Formula
    C23H48N6O17S
    Molecular Weight
    712.7  g/mol
    InChI Key
    OIXVKQDWLFHVGR-VTSVPHRWSA-N
    Neomycin Sulfate
    Aminoglycoside antibiotic complex produced by Streptomyces fradiae. It is composed of neomycins A, B, and C, and acts by inhibiting translation during protein synthesis.
    1 2D Structure

    Neomycin Sulfate

    2 Identification
    2.1 Computed Descriptors
    2.1.1 IUPAC Name
    (2R,3R,4R,5R,6R)-5-amino-2-(aminomethyl)-6-[(1R,2S,3S,4R,6S)-4,6-diamino-2-[(2S,3R,4R,5R)-4-[(3R,4R,5R,6S)-3-amino-6-(aminomethyl)-4,5-dihydroxyoxan-2-yl]oxy-3-hydroxy-5-(hydroxymethyl)oxolan-2-yl]oxy-3-hydroxycyclohexyl]oxyoxane-3,4-diol;sulfuric acid
    2.1.2 InChI
    InChI=1S/C23H46N6O13.H2O4S/c24-2-7-13(32)15(34)10(28)21(37-7)40-18-6(27)1-5(26)12(31)20(18)42-23-17(36)19(9(4-30)39-23)41-22-11(29)16(35)14(33)8(3-25)38-22;1-5(2,3)4/h5-23,30-36H,1-4,24-29H2;(H2,1,2,3,4)/t5-,6+,7-,8+,9-,10-,11-,12+,13+,14+,15-,16-,17-,18-,19+,20+,21-,22?,23+;/m1./s1
    2.1.3 InChI Key
    OIXVKQDWLFHVGR-VTSVPHRWSA-N
    2.1.4 Canonical SMILES
    C1C(C(C(C(C1N)OC2C(C(C(C(O2)CN)O)O)N)OC3C(C(C(O3)CO)OC4C(C(C(C(O4)CN)O)O)N)O)O)N.OS(=O)(=O)O
    2.1.5 Isomeric SMILES
    C1[C@H]([C@@H]([C@@H]([C@@H]([C@H]1N)O[C@@H]2[C@@H]([C@H]([C@H]([C@H](O2)CN)O)O)N)O[C@H]3[C@@H]([C@H]([C@H](O3)CO)OC4[C@@H]([C@H]([C@H]([C@@H](O4)CN)O)O)N)O)O)N.OS(=O)(=O)O
    2.2 Synonyms
    2.2.1 MeSH Synonyms

    1. Neomycin

    2. Neomycin Palmitate

    3. Neomycin Sulfate

    2.2.2 Depositor-Supplied Synonyms

    1. Neomycin Sulfate

    2. 1405-10-3

    3. Neomycin Trisulfate Hydrate

    4. Akos016010116

    2.3 Create Date
    2013-05-31
    3 Chemical and Physical Properties
    Molecular Weight 712.7 g/mol
    Molecular Formula C23H48N6O17S
    Hydrogen Bond Donor Count15
    Hydrogen Bond Acceptor Count23
    Rotatable Bond Count9
    Exact Mass712.27966526 g/mol
    Monoisotopic Mass712.27966526 g/mol
    Topological Polar Surface Area436 Ų
    Heavy Atom Count47
    Formal Charge0
    Complexity953
    Isotope Atom Count0
    Defined Atom Stereocenter Count18
    Undefined Atom Stereocenter Count1
    Defined Bond Stereocenter Count0
    Undefined Bond Stereocenter Count0
    Covalently Bonded Unit Count2
    4 Drug and Medication Information
    4.1 Drug Information
    1 of 2  
    Drug NameNeomycin sulfate
    Drug LabelNeomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomycesfradiae. Structurally, neomycin sulfate may be represented as follows:Chemically, i...
    Active IngredientNeomycin sulfate
    Dosage FormTablet
    RouteOral
    Strength500mg
    Market StatusPrescription
    CompanyOman Pharm Products; Teva; X Gen Pharms

    2 of 2  
    Drug NameNeomycin sulfate
    Drug LabelNeomycin Sulfate Tablets, USP, for oral administration, contain neomycin which is an antibiotic obtained from the metabolic products of the actinomycete Streptomycesfradiae. Structurally, neomycin sulfate may be represented as follows:Chemically, i...
    Active IngredientNeomycin sulfate
    Dosage FormTablet
    RouteOral
    Strength500mg
    Market StatusPrescription
    CompanyOman Pharm Products; Teva; X Gen Pharms

    5 Pharmacology and Biochemistry
    5.1 MeSH Pharmacological Classification

    Anti-Bacterial Agents

    Substances that inhibit the growth or reproduction of BACTERIA. (See all compounds classified as Anti-Bacterial Agents.)

    Protein Synthesis Inhibitors

    Compounds which inhibit the synthesis of proteins. They are usually ANTI-BACTERIAL AGENTS or toxins. Mechanism of the action of inhibition includes the interruption of peptide-chain elongation, the blocking the A site of ribosomes, the misreading of the genetic code or the prevention of the attachment of oligosaccharide side chains to glycoproteins. (See all compounds classified as Protein Synthesis Inhibitors.)

    5.2 FDA Pharmacological Classification
    5.2.1 Pharmacological Classes
    Aminoglycosides [CS]; Aminoglycoside Antibacterial [EPC]

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MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.8 ZIYANG ROAD, DIANJUN DISTRICT YICHANG CITY, HUBEI PROVINCE, P.R SDNF CN","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764009000,"product":"NEOMYCIN SULPHATE IP (60 BOU) NEOMYCIN SULPHATE IP (60 BOU)","address":"217, 2ND FLOOR, KAMLA SPACES,","city":"MUMBAI, MAHARASHTRA","supplier":"UNDISCLOSED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RELY CHEM","customerCountry":"INDIA","quantity":"91.20","actualQuantity":"91.2","unit":"KGS","unitRateFc":"21.7","totalValueFC":"1996.2","currency":"USD","unitRateINR":"1945.4","date":"25-Nov-2025","totalValueINR":"177421.82","totalValueInUsd":"1996.2","indian_port":"JNPT","hs_no":"29419050","bill_no":"562","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NF","customerAddress":"217, 2ND FLOOR, KAMLA SPACES,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764009000,"product":"NEOMYCIN SULPHATE IP (900 BOU) NEOMYCIN SULPHATE IP (900 BOU)","address":"217, 2ND FLOOR, KAMLA SPACES,","city":"MUMBAI, MAHARASHTRA","supplier":"UNDISCLOSED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"RELY CHEM","customerCountry":"INDIA","quantity":"1354.50","actualQuantity":"1354.5","unit":"KGS","unitRateFc":"20","totalValueFC":"27220.5","currency":"USD","unitRateINR":"1786.2","date":"25-Nov-2025","totalValueINR":"2419388.85","totalValueInUsd":"27220.5","indian_port":"JNPT","hs_no":"29419050","bill_no":"562","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NF","customerAddress":"217, 2ND FLOOR, KAMLA SPACES,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764181800,"product":"NEOMYCIN SULPHATE IP (75BOU) (15BOU\/DRUM) NET 114 KGS NEOMYCIN SULPHATE IP (75BOU) (15BOU\/DRUM) NET 114 KGS","address":"DR ANNIE BESANT ROAD","city":"MUMBAI ,MAHARASHTRA","supplier":"YICHANG SANXIA PHARMACEUTICAL CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GLAXOSMITHKLINE PHARMACEUTICALS LTD","customerCountry":"INDIA","quantity":"114.00","actualQuantity":"114","unit":"KGS","unitRateFc":"55.9","totalValueFC":"6419.4","currency":"USD","unitRateINR":"5004.9","date":"27-Nov-2025","totalValueINR":"570562.5","totalValueInUsd":"6419.4","indian_port":"JNPT","hs_no":"29419050","bill_no":"8900","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"NO.8 ZIYANG ROAD, DIANJUN DISTRICT YICHANG CITY, HUBEI PROVINCE, P.R SDNF CN","customerAddress":"DR ANNIE BESANT ROAD"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764613800,"product":"NEOMYCIN SULPHATE (VET) IP. (3000 BOU). NEOMYCIN SULPHATE (VET) IP. (3000 BOU).","address":"48, CHANDRA GUPTA ESTATE,","city":"MUMBAI, MAHARASHTRA.","supplier":"BRILLIANT PHARMACEUTICAL LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GORANG INTERNATIONAL","customerCountry":"INDIA","quantity":"4734.01","actualQuantity":"4734.01","unit":"KGS","unitRateFc":"11.4","totalValueFC":"53762.4","currency":"USD","unitRateINR":"1022.1","date":"02-Dec-2025","totalValueINR":"4838660.88","totalValueInUsd":"53762.4","indian_port":"JNPT","hs_no":"29419050","bill_no":"73258","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"OFFICE F, 32\/F, PLAZA 88 NO.88 YEUN G UK ROAD, TSUEN WAN NT, HONG KONG CHINA ., ., China China","customerAddress":"48, CHANDRA GUPTA ESTATE,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1764786600,"product":"NEOMYCIN SULPHATE IP (500 BOU)","address":"501-502,AMBA SADAN,","city":"MUMBAI,MAHARASHTRA","supplier":"UNDISCLOSED","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"GENERAL IMPORT CO INDIA PRIVATE LTD","customerCountry":"INDIA","quantity":"758.00","actualQuantity":"758","unit":"KGS","unitRateFc":"19.8","totalValueFC":"14960.8","currency":"USD","unitRateINR":"1776.4","date":"04-Dec-2025","totalValueINR":"1346483","totalValueInUsd":"14960.8","indian_port":"JNPT","hs_no":"29419050","bill_no":"8","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"N\/A","customerAddress":"501-502,AMBA SADAN,"},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766428200,"product":"API NEOMYCIN SULPHATE USP43 ( CAS NO: 1405-10-3) NEOMYCIN SULFATE","address":"213, LAXMI PLAZA, LAXMI INDL.","city":"MUMBAI, MAHARASHTRA","supplier":"ADIA SHANGHAI PHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ASHISH LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"30.50","actualQuantity":"30.5","unit":"KGS","unitRateFc":"12.9","totalValueFC":"399","currency":"CNY","unitRateINR":"1177.4","date":"23-Dec-2025","totalValueINR":"35910.72","totalValueInUsd":"399","indian_port":"JNPT","hs_no":"29419090","bill_no":"3","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"SUITE 27G, WORLD PLAZA, 855 SOUTH PUDONG ROAD, PUDONG, SHANGHAI 200120, CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766428200,"product":"API NEOMYCIN SULPHATE USP43 ( CAS NO: 1405-10-3) NEOMYCIN SULFATE","address":"213, LAXMI PLAZA, LAXMI INDL.","city":"MUMBAI, MAHARASHTRA","supplier":"ADIA SHANGHAI PHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ASHISH LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"262.50","actualQuantity":"262.5","unit":"KGS","unitRateFc":"12.9","totalValueFC":"3434.1","currency":"CNY","unitRateINR":"1177.4","date":"23-Dec-2025","totalValueINR":"309067.63","totalValueInUsd":"3434.1","indian_port":"JNPT","hs_no":"29419090","bill_no":"3","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"SUITE 27G, WORLD PLAZA, 855 SOUTH PUDONG ROAD, PUDONG, SHANGHAI 200120, CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."},{"dataSource":"API Import","activeIngredients":"","year":"2025","qtr":"Q4","strtotime":1766428200,"product":"API NEOMYCIN SULPHATE USP43 ( CAS NO: 1405-10-3) NEOMYCIN SULFATE","address":"213, LAXMI PLAZA, LAXMI INDL.","city":"MUMBAI, MAHARASHTRA","supplier":"ADIA SHANGHAI PHARMA CO LTD","supplierCountry":"CHINA","foreign_port":"SHANGHAI","customer":"ASHISH LIFE SCIENCE PRIVATE LTD","customerCountry":"INDIA","quantity":"707.00","actualQuantity":"707","unit":"KGS","unitRateFc":"12.9","totalValueFC":"9249","currency":"CNY","unitRateINR":"1177.4","date":"23-Dec-2025","totalValueINR":"832422.15","totalValueInUsd":"9249","indian_port":"JNPT","hs_no":"29419090","bill_no":"3","productDescription":"API","marketType":"REGULATED MARKET","country":"CHINA","selfForZScoreResived":"Pharma Grade","supplierPort":"SHANGHAI","supplierAddress":"SUITE 27G, WORLD PLAZA, 855 SOUTH PUDONG ROAD, PUDONG, SHANGHAI 200120, CHINA","customerAddress":"213, LAXMI PLAZA, LAXMI INDL."}]
    12-Jan-2022
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    Drugs in Development

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    • Development Update
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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

    Details:

    Bacillus Clausii is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gastroenteritis.


    Lead Product(s): Bacillus Clausii,Neomycin Sulfate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Undisclosed

    Study Phase: Phase IVProduct Type: Undisclosed

    Sponsor: Undisclosed

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable June 23, 2014

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    Sanofi

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    Virtual BoothSanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.

    Lead Product(s) : Bacillus Clausii,Neomycin Sulfate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Phase IV

    Partner/Sponsor/Collaborator : Undisclosed

    Deal Size : Inapplicable

    Deal Type : Inapplicable

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    Evaluation Of Bacillus Clausii In Treatment Of Acute Diarrhea In Latin American Children

    Details : Bacillus Clausii is a drug candidate, which is currently being evaluated in phase IV clinical studies for the treatment of Gastroenteritis.

    Product Name : Undisclosed

    Product Type : Undisclosed

    Upfront Cash : Inapplicable

    June 23, 2014

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    Nordic Pharma Launches Authorized Generic of Maxitrol in the U.S.

    Details:

    The partnership aims to launch an Maxitrol-Generic (Neomycin/Polymyxin B Sulfates/Dexamethasone) ophthalmic suspension, which treats and relieves bacterial eye infections.


    Lead Product(s): Dexamethasone,Neomycin Sulfate,Polymyxin B Sulfate

    Therapeutic Area: Infections and Infectious Diseases Brand Name: Maxitrol-Generic

    Study Phase: Approved FDFProduct Type: Steroid

    Sponsor: Harrow

    Deal Size: Undisclosed Upfront Cash: Undisclosed

    Deal Type: Partnership April 24, 2025

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    Nordic Pharma

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    Nordic Pharma

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    Lead Product(s) : Dexamethasone,Neomycin Sulfate,Polymyxin B Sulfate

    Therapeutic Area : Infections and Infectious Diseases

    Highest Development Status : Approved FDF

    Partner/Sponsor/Collaborator : Harrow

    Deal Size : Undisclosed

    Deal Type : Partnership

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    Nordic Pharma Launches Authorized Generic of Maxitrol in the U.S.

    Details : The partnership aims to launch an Maxitrol-Generic (Neomycin/Polymyxin B Sulfates/Dexamethasone) ophthalmic suspension, which treats and relieves bacterial eye infections.

    Product Name : Maxitrol-Generic

    Product Type : Steroid

    Upfront Cash : Undisclosed

    April 24, 2025

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    Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

    Details:

    Neomycin Sulfate is a Plant Extract/Herbal drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Vaginitis.


    Lead Product(s): Neomycin Sulfate,Polymyxin B Sulfate,Nystatin

    Therapeutic Area: Obstetrics/Gynecology (Women’s Health) Brand Name: Undisclosed

    Study Phase: Phase IIIProduct Type: Plant Extract/Herbal

    Sponsor: International Clinical Trials Association | Venn Life Sciences

    Deal Size: Inapplicable Upfront Cash: Inapplicable

    Deal Type: Inapplicable August 05, 2015

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    Laboratoire Innotech International

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    Lead Product(s) : Neomycin Sulfate,Polymyxin B Sulfate,Nystatin

    Therapeutic Area : Obstetrics/Gynecology (Women’s Health)

    Highest Development Status : Phase III

    Partner/Sponsor/Collaborator : International Clinical Trials Association | Venn Life Sciences

    Deal Size : Inapplicable

    Deal Type : Inapplicable

    DEALS_DEV arrow-down

    Assessment of the Efficacy of POLYGYNAX® in the Empirical Treatment of Infectious Vaginitis

    Details : Neomycin Sulfate is a Plant Extract/Herbal drug candidate, which is currently being evaluated in phase III clinical studies for the treatment of Vaginitis.

    Product Name : Undisclosed

    Product Type : Plant Extract/Herbal

    Upfront Cash : Inapplicable

    August 05, 2015

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    FDA Orange Book

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    ALLERGAN

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    RLD : No

    TE Code :

    NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE

    Brand Name : POLY-PRED

    Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

    Dosage Strength : EQ 0.35% BASE;10,000 UNITS/ML;0.5%

    Approval Date : 1982-01-01

    Application Number : 50081

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

    Abbvie CB

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    WATSON LABS

    Ireland
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    WATSON LABS

    Ireland
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    RLD : No

    TE Code : AT

    NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : NEOMYCIN AND POLYMYXIN B SULFATE

    Dosage Form : SOLUTION;IRRIGATION

    Dosage Strength : EQ 40MG BASE/ML;200,000 UNITS/ML

    Approval Date : 1986-04-08

    Application Number : 62664

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    BAUSCH AND LOMB

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    BAUSCH AND LOMB

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    RLD : No

    TE Code : AT

    DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : DEXASPORIN

    Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

    Dosage Strength : 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML

    Approval Date : 1995-09-13

    Application Number : 64135

    RX/OTC/DISCN : RX

    RLD : No

    TE Code : AT

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    BAYER PHARMS

    Germany
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    BAYER PHARMS

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    RLD : No

    TE Code :

    HYDROCORTISONE; NEOMYCIN SULFATE

    Brand Name : NEO-CORT-DOME

    Dosage Form : CREAM;TOPICAL

    Dosage Strength : 1%;EQ 3.5MG BASE/GM

    Approval Date : 1984-06-05

    Application Number : 50237

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    LILLY

    U.S.A
    BIO Partnering at JPM
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    LILLY

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    RLD : No

    TE Code :

    FLURANDRENOLIDE; NEOMYCIN SULFATE

    Brand Name : CORDRAN N

    Dosage Form : CREAM;TOPICAL

    Dosage Strength : 0.05%;EQ 3.5MG BASE/GM

    Approval Date : 1982-01-01

    Application Number : 50346

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    EPIC PHARMA LLC

    U.S.A
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    EPIC PHARMA LLC

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    RLD : No

    TE Code :

    HYDROCORTISONE ACETATE; NEOMYCIN SULFATE

    Brand Name : COR-OTICIN

    Dosage Form : SUSPENSION/DROPS;OPHTHALMIC

    Dosage Strength : 1.5%;EQ 3.5MG BASE/ML

    Approval Date : 1982-01-01

    Application Number : 60188

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    LANNETT

    U.S.A
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    LANNETT

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    RLD : No

    TE Code :

    NEOMYCIN SULFATE

    Brand Name : NEOMYCIN SULFATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

    Approval Date : 1982-01-01

    Application Number : 60607

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    PHARMACIA AND UPJOHN

    U.S.A
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    PHARMACIA AND UPJOHN

    U.S.A
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    RLD : No

    TE Code :

    BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE

    Brand Name : MYCITRACIN

    Dosage Form : OINTMENT;OPHTHALMIC

    Dosage Strength : 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

    Approval Date : 1982-01-01

    Application Number : 61048

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    PHARMADERM

    U.S.A
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    PHARMADERM

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    RLD : No

    TE Code :

    NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE

    Brand Name : NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE

    Dosage Form : CREAM;TOPICAL

    Dosage Strength : EQ 3.5MG BASE/GM;0.1%

    Approval Date : 1986-07-21

    Application Number : 62595

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    ROXANE

    U.S.A
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    ROXANE

    U.S.A
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    RLD : No

    TE Code :

    NEOMYCIN SULFATE

    Brand Name : NEOMYCIN SULFATE

    Dosage Form : TABLET;ORAL

    Dosage Strength : 500MG

    Approval Date : 1982-01-01

    Application Number : 62173

    RX/OTC/DISCN : DISCN

    RLD : No

    TE Code :

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    Only 10 entries up to this point, click to access all click full view read-more
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    DRUG PRODUCT COMPOSITIONS

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    DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG ...DOSAGE - OINTMENT;OPHTHALMIC - 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM

    USFDA APPLICATION NUMBER - 50065

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    DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;E...DOSAGE - OINTMENT;TOPICAL - 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50168

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    DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/G...DOSAGE - CREAM;TOPICAL - 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

    USFDA APPLICATION NUMBER - 50218

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    DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/...DOSAGE - SUSPENSION/DROPS;OTIC - EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG BASE/ML;0.5MG/ML

    USFDA APPLICATION NUMBER - 50356

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    DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;E...DOSAGE - OINTMENT;OPHTHALMIC - 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 UNITS/GM

    USFDA APPLICATION NUMBER - 50417

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    ABOUT THIS PAGE

    Looking for 1405-10-3 / Neomycin Sulfate API manufacturers, exporters & distributors?

    Neomycin Sulfate manufacturers, exporters & distributors 1

    22

    PharmaCompass offers a list of Neomycin Sulfate API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Neomycin Sulfate manufacturer or Neomycin Sulfate supplier for your needs.

    Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Neomycin Sulfate manufacturer or Neomycin Sulfate supplier.

    PharmaCompass also assists you with knowing the Neomycin Sulfate API Price utilized in the formulation of products. Neomycin Sulfate API Price is not always fixed or binding as the Neomycin Sulfate Price is obtained through a variety of data sources. The Neomycin Sulfate Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

    API | Excipient name

    Neomycin Sulfate

    Synonyms

    1405-10-3, Neomycin trisulfate hydrate, Akos016010116

    Cas Number

    1405-10-3

    About Neomycin Sulfate

    Aminoglycoside antibiotic complex produced by Streptomyces fradiae. It is composed of neomycins A, B, and C, and acts by inhibiting translation during protein synthesis.

    MYCITRACIN-1 Manufacturers

    A MYCITRACIN-1 manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of MYCITRACIN-1, including repackagers and relabelers. The FDA regulates MYCITRACIN-1 manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. MYCITRACIN-1 API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

    click here to find a list of MYCITRACIN-1 manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

    MYCITRACIN-1 Suppliers

    A MYCITRACIN-1 supplier is an individual or a company that provides MYCITRACIN-1 active pharmaceutical ingredient (API) or MYCITRACIN-1 finished formulations upon request. The MYCITRACIN-1 suppliers may include MYCITRACIN-1 API manufacturers, exporters, distributors and traders.

    click here to find a list of MYCITRACIN-1 suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

    MYCITRACIN-1 USDMF

    A MYCITRACIN-1 DMF (Drug Master File) is a document detailing the whole manufacturing process of MYCITRACIN-1 active pharmaceutical ingredient (API) in detail. Different forms of MYCITRACIN-1 DMFs exist exist since differing nations have different regulations, such as MYCITRACIN-1 USDMF, ASMF (EDMF), JDMF, CDMF, etc.

    A MYCITRACIN-1 DMF submitted to regulatory agencies in the US is known as a USDMF. MYCITRACIN-1 USDMF includes data on MYCITRACIN-1's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The MYCITRACIN-1 USDMF is kept confidential to protect the manufacturer’s intellectual property.

    click here to find a list of MYCITRACIN-1 suppliers with USDMF on PharmaCompass.

    MYCITRACIN-1 JDMF

    The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

    The MYCITRACIN-1 Drug Master File in Japan (MYCITRACIN-1 JDMF) empowers MYCITRACIN-1 API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

    PMDA reviews the MYCITRACIN-1 JDMF during the approval evaluation for pharmaceutical products. At the time of MYCITRACIN-1 JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

    click here to find a list of MYCITRACIN-1 suppliers with JDMF on PharmaCompass.

    MYCITRACIN-1 KDMF

    In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

    Pharmaceutical companies submit a MYCITRACIN-1 Drug Master File in Korea (MYCITRACIN-1 KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of MYCITRACIN-1. The MFDS reviews the MYCITRACIN-1 KDMF as part of the drug registration process and uses the information provided in the MYCITRACIN-1 KDMF to evaluate the safety and efficacy of the drug.

    After submitting a MYCITRACIN-1 KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their MYCITRACIN-1 API can apply through the Korea Drug Master File (KDMF).

    click here to find a list of MYCITRACIN-1 suppliers with KDMF on PharmaCompass.

    MYCITRACIN-1 CEP

    A MYCITRACIN-1 CEP of the European Pharmacopoeia monograph is often referred to as a MYCITRACIN-1 Certificate of Suitability (COS). The purpose of a MYCITRACIN-1 CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of MYCITRACIN-1 EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of MYCITRACIN-1 to their clients by showing that a MYCITRACIN-1 CEP has been issued for it. The manufacturer submits a MYCITRACIN-1 CEP (COS) as part of the market authorization procedure, and it takes on the role of a MYCITRACIN-1 CEP holder for the record. Additionally, the data presented in the MYCITRACIN-1 CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the MYCITRACIN-1 DMF.

    A MYCITRACIN-1 CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. MYCITRACIN-1 CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

    click here to find a list of MYCITRACIN-1 suppliers with CEP (COS) on PharmaCompass.

    MYCITRACIN-1 NDC

    National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing MYCITRACIN-1 as an active pharmaceutical ingredient (API).

    Finished drug products

    The FDA updates the NDC directory daily. The NDC numbers for MYCITRACIN-1 API and other APIs are published in this directory by the FDA.

    Unfinished drugs

    The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

    Pharmaceutical companies that manufacture MYCITRACIN-1 as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

    Compounded drug products

    The NDC directory also contains data on finished compounded human drug products that contain MYCITRACIN-1 and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a MYCITRACIN-1 NDC to their finished compounded human drug products, they may choose to do so.

    click here to find a list of MYCITRACIN-1 suppliers with NDC on PharmaCompass.

    MYCITRACIN-1 GMP

    MYCITRACIN-1 Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

    GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

    PharmaCompass offers a list of MYCITRACIN-1 GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right MYCITRACIN-1 GMP manufacturer or MYCITRACIN-1 GMP API supplier for your needs.

    MYCITRACIN-1 CoA

    A MYCITRACIN-1 CoA (Certificate of Analysis) is a formal document that attests to MYCITRACIN-1's compliance with MYCITRACIN-1 specifications and serves as a tool for batch-level quality control.

    MYCITRACIN-1 CoA mostly includes findings from lab analyses of a specific batch. For each MYCITRACIN-1 CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

    MYCITRACIN-1 may be tested according to a variety of international standards, such as European Pharmacopoeia (MYCITRACIN-1 EP), MYCITRACIN-1 JP (Japanese Pharmacopeia) and the US Pharmacopoeia (MYCITRACIN-1 USP).

    Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
    For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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